Assessing Efficacy of Intravenous Acetaminophen for Perioperative Pain Treatment in Spinal Surgery
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Worst pain score in the post-anesthesia care unit
研究概览
简要总结
Spinal surgeries are generally associated with intense pain in the postoperative period, especially for the initial few days. The aim of this study is to examine the effect of intraoperative intravenous acetaminophen in spine surgery on postoperative analgesic requirements, pain scores, patient satisfaction, and clinical recovery. Enrolled patients are randomized to receive either intravenous acetaminophen or placebo at the time of surgical closure. It is hypothesized that patients receiving intravenous acetaminophen will have improved pain scores, require less opiate medication, and have better patient satisfaction than those receiving placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing 1-2 levels primary spine surgery ≥18 years old
排除标准
- •Chronic opiate users
- •More than 3 levels or revision spine surgery
- •Liver disease patients include elevated LFT, hepatitis A, hepatitis B or hepatitis C, cirrhosis, fatty liver disease, and any other liver diseases caused by drugs, poisons, or alcohol(s)
- •Allergy/hypersensitivity to acetaminophen
- •Patients that have used acetaminophen during the 24 hours before their scheduled surgery
- •Subjects who were unable to communicate in English were further excluded because of their inability to complete the postoperative questionnaires
研究组 & 干预措施
Intravenous Acetaminophen
Intravenous acetaminophen (1000mg) will be administered within 30 minutes of skin closure.
干预措施: Acetaminophen (Drug)
Intravenous Placebo
Intravenous normal saline will be administered within 30 minutes of skin closure.
干预措施: Placebo (Drug)
结局指标
主要结局
Worst pain score in the post-anesthesia care unit
时间窗: Time of postoperative care unit discharge readiness, approximately 3 hours
The primary outcome will assess worst pain score at the time the patient is ready for post anesthesia care unit discharge using the Revised American Pain Society Patient Outcome Questionnaire. This scale ranges from 0 to 10, with higher values reporting more pain.
次要结局
- Postoperative pain scores(Postoperatively until 72 hours or discharge, approximately three days)
- Intraoperative opioid consumption(Intraoperatively)
- Postoperative opioid consumption in the post anesthesia care unit(Postoperatively until time of PACU discharge, approximately 3 hours.)
- Time to rescue analgesia(Postoperatively until discharge, an average of two days)
- Postoperative opioid consumption after discharge from the postoperative care(Time of discharge from the postoperative care unit until discharge from the hospital, an average of two days)
- Patient satisfaction(Time of postoperative care unit discharge readiness, approximately 3 hours.)
- Length of hospital stay(Postoperatively until discharge, an average of two days)
研究者
Jingping Wang, MD, Ph.D.
Associate Professor of Anaesthesia
Massachusetts General Hospital